- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical ... high-performing environment.Lead complex GCDS Operations projects within the area of clinical drug supply management .Oversee inspection readiness and ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE) department of NNI focused on clinical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and site staff, Health Systems, Contract Research Organizations and Site Management Organizations etc.) Establish and manage senior level relationships ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...teams, leading research projects, coordinating/managing research vendors, & budget management . RelationshipsThe fellow will report to the Senior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs organization Effectively communicate system vision, timelines and progress to senior management , collaborative partners and end users Responsible for ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position This role sits in the Clinical Data Sciences and Evidence (CDSE) Division. It plays an important role in ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Genmab (Plainsboro, NJ)
- …for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab ... Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Genmab (Plainsboro, NJ)
- …in the conduct of clinical trials in oncology. Proficiency in clinical data review and interpretation.Solid experience in translating medical/ clinical ... The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director, US Medical Affairs Solid Tumors Strategy Lead. S/he will provide medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with stakeholders across Clinical Medical and Regulatory (CMR), including the NACO senior leadership team and line of business management team, as well as ... maintaining strong communication channels. This position is accountable for the financial management and budget development of North America Clinical Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …complying with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... experiment with us? The Position This position is accountable for strategic management of contracted HCPs engaged as promotional speakers, consultants, advisors, or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in ... for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... business results and achieve organizational objectives Excellent communication and stakeholder management skills, with ability to influence senior leaders and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …proven track record of results and follow up Excellent communication and stakeholder management skills, with ability to influence senior leaders and collaborate ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
